Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia

Launched by ALIREZA SHAMSHIRSAZ · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a procedure called Fetal Endotracheal Occlusion (FETO) for babies diagnosed with a severe condition known as congenital diaphragmatic hernia (CDH). CDH occurs when there is a hole in the diaphragm, which can lead to underdeveloped lungs. The main goal of this study is to see if the FETO procedure can help improve lung growth before birth and increase the chances of survival after birth. The trial will involve 10 pregnant women who are between 27 and 29 weeks pregnant when they start, and they will be closely monitored throughout the process, including after their babies are born and until the children are 2 years old.

To take part in this trial, participants must be at least 18 years old, have a single baby on the way, and live near Boston Children's Hospital. They will need someone to support them during the pregnancy and be able to stay close to the hospital for the duration of the FETO treatment. There are some health conditions that could prevent a woman from joining the study, such as certain medical issues during pregnancy or if the baby has other serious complications. Overall, this trial aims to gather important information about the safety and effectiveness of the FETO procedure for babies with severe CDH.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant patient 18 and older who is able to consent
• • Singleton pregnancy
• • Ability to reside within 30 minutes of Boston Children's Hospital for the duration of the FETO intervention, from the time of balloon placement until balloon removal
• • Patient has a support person who is able to stay with them for the duration of the pregnancy
• Fetal:
• • Reassuring genetic analysis demonstrated by either normal Karyotype, normal fluorescence in situ hybridization (FISH) for chromosomes 13, 18, 21, X and Y, or chromosomal microarray (CMA) with non-pathologic variants
• • Diagnosis of isolated left CDH with liver up
• • Gestation at enrollment prior to 29 weeks 5 days
• • SEVERE pulmonary hypoplasia with ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%
• Exclusion Criteria:
• • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• • Technical limitations precluding fetoscopic surgery, including uterine anomaly such as large or multiple fibroids, or Mullerian duct anomaly
• • Latex allergy
• • Preterm labor, shortened cervix (\<20mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• • Severe maternal obesity pre-pregnancy (BMI \> 40)
• • Psychosocial ineligibility, precluding consent, as determined by clinic social worker during review
• • Inability to remain at FETO site during time period of tracheal occlusion, delivery, and postnatal care
• • Right-sided or bilateral, left-sided CDH observed-to-expected lung to head ratio \> 25% on ultrasound
• • Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis
• • History of incompetent cervix with or without cerclage
• • Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• • Maternal-fetal RH (rhesus) isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• • Maternal HIV, Hepatitis B, Hepatitis C status positive